Postoperative AnalgesiaNCT01589354
Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
A study testing Interscalene brachial plexus block, Intra-articular Ropivacaine injection and Ultrasound guided technique in people with Postoperative Analgesia, run by NHS Grampian.
Trial summary
This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and intra-articular local anaesthetic injection. Both techniques are currently used for providing postoperative pain relief following arthroscopic shoulder stabilisation operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Interscalene brachial plexus block, Intra-articular Ropivacaine injection and Ultrasound guided technique
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation
Who cannot join
- Patients not meeting inclusion criteria
- Patients unable to give informed consent
- Patient refusal to participate in the study
- Contraindications to Interscalene block
- Allergy to local anaesthetics
- Peripheral neuropathy from any cause
- Patients on opiates for chronic pain
- Pregnant women
About this study
This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and intra-articular local anaesthetic injection. Both techniques are currently used for providing postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be a randomised controlled trial involving 30 patients in two groups.
- Conditions
- Postoperative Analgesia
- Being tested
- Interscalene brachial plexus block, Intra-articular Ropivacaine injection, Ultrasound guided technique, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
An interscalene block will be performed pre-operatively using ultrasound guidance and the peripheral nerve stimulator (with the patient awake) using 20 ml of 0.375% Ropivacaine.
Intra-articular Ropivacaine injectionProcedure or surgery
The procedure will be done by the surgeon at the end of the operation, with an intra-articular injection of 20 ml 0.75% Ropivacaine through the arthroscopic cannula after closure of the anterior wound
Ultrasound guided techniqueDevice
The block will be performed under U/S guidance
RopivacaineDrug
20ml of 0.375% Ropivacaine
RopivacaineDrug
20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Interscalene brachial plexus block | Experimental | Not described Receives: Procedure: Interscalene brachial plexus block; Device: Ultrasound guided technique; Drug: Ropivacaine |
| Intra-articular injection | Experimental | Not described Receives: Procedure: Intra-articular Ropivacaine injection; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation
Measured: 24 months
Secondary outcomes (2)
Post-operative analgesic requirements in the first 24 hours after surgery
Measured: 24 months
Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr M Mahdy, NHS Grampian
- Investigators
- Amr M Mahdy, MD, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589354
- Sponsor's protocol ID
- 10/S0801/74
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery
- ClinicalTrials.gov ID
- NCT01589354
- Acronym / sponsor ID
- 10/S0801/74
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS GrampianOther government
- Study start
- May 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates two anaesthetic techniques namely interscalene brachial plexus block and intra-articular local anaesthetic injection. Both techniques are currently used for providing postoperative pain relief following arthroscopic shoulder stabilisation operation. It will be a randomised controlled trial involving 30 patients in two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block | Experimental | Procedure: Interscalene brachial plexus block, Device: Ultrasound guided technique, Drug: Ropivacaine |
| Intra-articular injection | Experimental | Procedure: Intra-articular Ropivacaine injection, Drug: Ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients above the age of 18 years undergoing arthroscopic shoulder stabilisation operation
Key exclusion criteria (8 listed)
- Patients not meeting inclusion criteria
- Patients unable to give informed consent
- Patient refusal to participate in the study
- Contraindications to Interscalene block
- Allergy to local anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockAn interscalene block will be performed pre-operatively using ultrasound guidance and the peripheral nerve stimulator (with the patient awake) using 20 ml of 0.375% Ropivacaine. | Procedure or surgery | Interscalene brachial plexus block |
| Intra-articular Ropivacaine injectionThe procedure will be done by the surgeon at the end of the operation, with an intra-articular injection of 20 ml 0.75% Ropivacaine through the arthroscopic cannula after closure of the anterior wound | Procedure or surgery | Intra-articular injection |
| Ultrasound guided techniqueThe block will be performed under U/S guidance | Device | Interscalene brachial plexus block |
| Ropivacaine20ml of 0.375% Ropivacaine | Drug | Interscalene brachial plexus block |
| Ropivacaine20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure | Drug | Intra-articular injection |
Primary outcome
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation
Time frame: 24 months
2 secondary outcomes
Post-operative analgesic requirements in the first 24 hours after surgery
Time frame: 24 months
Patient assessment of quality of analgesia and identifying any complications as a result of the two anaesthetic procedures
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr M Mahdy, MD principal investigator
NHS Grampian
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus block, Intra-articular Ropivacaine injection and Ultrasound guided technique in people with Postoperative Analgesia, run by NHS Grampian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain score over the first 24 hours following arthroscopic shoulder stabilisation operation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.